New York State Health Department Alerts Healthcare Facilities, Providers and Pharmacists to Recall of Products from Med Prep Consulting, Inc.
ALBANY, N.Y. (March 21, 2013) – With the announcement of a nationwide, voluntary recall of products compounded by Med Prep Consulting, Inc. (MPC), the New York State Department of Health (DOH) is advising hospitals and other healthcare facilities, healthcare providers, and pharmacists in the state, to immediately stop using all products compounded by MPC.
The recall is in response to visible particulate contaminants observed in intravenous solution received by a Connecticut hospital from MPC. On March 16, 2013, the federal Food and Drug Administration (FDA) announced a voluntary recall of all lots of magnesium sulfate compounded by MPC because of the potential for mold contamination. Due to lack of assurance of sterility of its products, the voluntarily recall has been expanded to include all lots of all products compounded at MPC's Tinton Falls, N.J. facility.
The products, distributed through March 13, 2013, were manufactured for a wide range of uses for hospital inpatients and outpatients, and patients treated at physician offices and clinics. No products were dispensed directly to patients from retail pharmacies or to home care patients. To date, there have been no injuries or deaths reported from product use.
Details about the recall, including a list of Med Prep products, are available at the FDA web site at: http://www.fda.gov/Safety/Recalls/ucm344229.htm. Facilities should check to see if they received any products compounded by MPC, and if so should immediately remove these products and return them to the company.
Hospitals, health care facilities and health care providers who become aware of a possible fungal injection in a patient who received an MPC product have been advised to immediately contact their local health department.